news

9 August 2017

InDex Pharmaceuticals receives orphan-drug designation for pediatric ulcerative colitis in the US

InDex Pharmaceuticals Holding AB (publ) today announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation for the drug candidate cobitolimod for treatment of ulcerative colitis in pediatric patients.

“We are pleased that the FDA has granted orphan-drug designation for cobitolimod for treatment of ulcerative colitis in children, which may provide seven years of market exclusivity in this indication on the US market,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “The decision shows the medical need for new therapeutic options for this patient population and gives InDex additional opportunities to interact with the FDA.”